TelePharm PrEP/PEP
7 de mayo de 2026 actualizado por: Katrina Ortblad, Fred Hutchinson Cancer Center
Leveraging Telehealth to Optimize PrEP and PEP Delivery at Pharmacies in Kenya
In this study, the investigators will evaluate whether introducing a remote nurse to screen, counsel, and guide clients through HIV self-testing (via a telehealth platform) and support interested clients (via SMS) between pharmacy visits increases PrEP/PEP initiations and continuation compared to standard PrEP/PEP delivery by pharmacy providers.
The investigators hypothesize that pharmacy PrEP/PEP services delivered with telehealth support will result in better service utilization and implementation outcomes compared to standard delivery and be cost-effective to implement.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
Participating study pharmacies will be 1:1 randomized 24 pharmacies (n=1,580 clients ≥15 years) to either: 1) telehealth support, where a remote nurse screens, counsels, and guides clients through HIV self-testing (HIVST) and, between visits, communicates with interested clients via 2-way SMS, or 2) standard delivery, where the pharmacy provider performs all delivery tasks and clients are not given additional support.
The primary outcomes are PrEP/PEP initiation and continuation, assessed 180 days following clients' first pharmacy PrEP/PEP visit.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
1580
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Katrina F Ortblad
- Número de teléfono: 206-667-7267
- Correo electrónico: kortblad@fredhutch.org
Ubicaciones de estudio
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Kisumu, Kenia
- Kenya Medical Research Institute
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Contacto:
- Elizabeth A Bukusi
- Número de teléfono: +254-572021036
- Correo electrónico: ebukusi@rctp.or.ke
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Investigador principal:
- Elizabeth A Bukusi
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
Pharmacies
- Registered with the Pharmacy and Poisons Board (PPB)
- Must have at least one full-time licensed pharmacist or pharmaceutical technologist on staff
- Must have a private room where HIV testing and PrEP/PEP counseling can occur
- >3 km from other study pharmacies
- Willing to participate in research activities, including 2-day training for pharmacy providers
- Willing to share pharmacy records with us
- Sells HIVST kits that are WHO certified.
Pharmacists/remote nurses
- ≥ 18 years old
- Licensed pharmacist, pharmaceutical technologist, or nurse
- Willing to provide PrEP and PEP services, including HIV testing and associated counseling services
- Willing to complete training on PEP/PrEP service delivery at pharmacies, including certification for rapid diagnostic testing
- Able and willing to provide informed consent
Clients
- ≥ 15 years old
- Interested in being screened for PrEP or PEP
- Meets all criteria to be eligible for pharmacy-delivered PrEP or PEP on the Prescribing Checklist, including being at risk for HIV and not having any medical conditions that might contraindicate PrEP/PEP safety
- Able and willing to provide informed consent
Exclusion Criteria:
Clients
- Unwilling to provide a phone number at which an RA can reach them for completing surveys and communicate important study-related information
- Currently enrolled in any other HIV vaccine or prevention trial
- Have a condition that would preclude provision of informed consent, make study participation unsafe, complicate interpretation of outcome data, or otherwise interfere with achieving study objectives
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Telehealth support
Pharmacy provider-led PrEP/PEP delivery, with telehealth support from remote nurses for counseling and testing at or between pharmacy visits (includes guided HIV self-testing and optional 2-way SMS with remote nurses).
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Remote nurses screen, counsel, and guide HIV self-testing for pharmacy clients; pharmacy providers dispense PrEP or PEP.
SMS support from remote nurses available between pharmacy visits.
|
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Comparador activo: Standard delivery
Pharmacy provider-led PrEP/PEP delivery, without telehealth support from remote nurses for counseling and testing at or between pharmacy visits (includes guided HIV self-testing).
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Pharmacy provider screen, counsel, and guide HIV self-testing for pharmacy clients, and dispense PrEP or PEP.
SMS support not available between pharmacy visits.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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PrEP/PEP initiation
Periodo de tiempo: 18 months post implementation
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Pharmacy-level; count outcome: # of unique clients dispensed any form of PrEP or PEP over the implementation period
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18 months post implementation
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PrEP/PEP continuation
Periodo de tiempo: 18 months post implementation
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Pharmacy-level; count outcome: # of unique clients that refilled PrEP, transitioned from PEP-to-PrEP, or were dispensed PEP or on-demand PrEP 1+ times over the implementation period
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18 months post implementation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
PrEP initiation
Periodo de tiempo: 18 months post implementation
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Pharmacy-level; count outcome: # of unique clients dispensed any form of PrEP over the implementation period
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18 months post implementation
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PEP initiation
Periodo de tiempo: 18 months post implementation
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Pharmacy-level; count outcome: # unique clients dispensed any form of PEP over the implementation period
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18 months post implementation
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PrEP/PEP use
Periodo de tiempo: 1.5 and 6 months from initiation
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Pharmacy-level; count outcome: # of unique clients who swallowed any PrEP or PEP during the implementation period
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1.5 and 6 months from initiation
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PrEP use
Periodo de tiempo: 1.5 and 6 months from initiation
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Pharmacy-level; count outcome: # of unique clients who swallowed any PrEP during the implementation period
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1.5 and 6 months from initiation
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PEP use
Periodo de tiempo: 1.5 and 6 months from initiation
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Pharmacy-level; count outcome: # of unique clients who swallowed any PEP during the implementation period
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1.5 and 6 months from initiation
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PrEP refill
Periodo de tiempo: 18 months post implementation
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Pharmacy-level; count outcome: # of unique clients who refilled PrEP after initiating PrEP
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18 months post implementation
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Repeat PEP
Periodo de tiempo: 18 months post implementation
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Pharmacy-level; count outcome: # unique clients who were dispensed PEP or PEP-in-pocket after initiating PEP
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18 months post implementation
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PEP-to-PrEP
Periodo de tiempo: 18 months post implementation
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Pharmacy-level; count outcome: # unique clients who were dispensed PrEP after initiating PEP (any form) over the implementation period
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18 months post implementation
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Engaged with 1+ product
Periodo de tiempo: 18 months post implementation
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Pharmacy-level; count outcome: # of unique clients that were dispensed more than one HIV prevention product (oral PrEP, injectable PrEP, PEP, etc) over the implementation period
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18 months post implementation
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On-demand PrEP use
Periodo de tiempo: 6 months from initiation
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Pharmacy-level; count outcome: # of unique clients who were dispensed and swallowed any on-demand PrEP over the implementation period
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6 months from initiation
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PEP-in-Pocket use
Periodo de tiempo: 6 months from initiation
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Pharmacy-level; count outcome: # of unique clients who were dispensed and swallowed any PEP-in-Pocket over the implementation period
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6 months from initiation
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Product choice
Periodo de tiempo: 18 months post implementation
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Individual-level; binary outcome: % of total PrEP/PEP clients that were dispensed each type of product (e.g., oral PrEP, on- demand PrEP, PEP, DVR, etc).
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18 months post implementation
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PrEP adherence
Periodo de tiempo: 1.5 months from initiation
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Individual-level; binary outcome: % PrEP initiators (excluding on-demand) with optimal TFV-DP concentration in DBS
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1.5 months from initiation
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Reach
Periodo de tiempo: 18 months post implementation
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Individual-level; binary outcome: % of PrEP/PEP clients in different populations of interest (e.g., men; youth <25 years); with separate evaluations by product type
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18 months post implementation
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Efficiency
Periodo de tiempo: 18 months post implementation
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Pharmacy-level; continuous outcome: Avg.
duration (per visit & annually) of pharmacy providers' encounter per PrEP/PEP client, and clients' PrEP/PEP visit duration
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18 months post implementation
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Fidelity
Periodo de tiempo: 1.5 months post initiation
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Individual-level; binary outcome: % of clients that received PrEP/PEP services as intended (e.g., correct quantity of drugs)
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1.5 months post initiation
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Sustainment
Periodo de tiempo: 24 months post implementation
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Pharmacy-level; count outcome: Volume of unique PrEP/PEP clients served in the past 6 months, assessed at 24 months
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24 months post implementation
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Acceptability
Periodo de tiempo: 24 months post implementation
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Individual-level; cont, binary outcome: # of unique client who find the study components acceptable; % of providers, including remote nurses, indicating acceptability; Also assessed in Aim 2 (described below)
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24 months post implementation
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time to use (for on-demand PrEP) at 1.5 months
Periodo de tiempo: 1.5 months
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Pharmacy-level; continuous outcome: Avg.
duration (in days) from on-demand PrEP dispensing to use, among on-demand clients
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1.5 months
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Time to use (for on-demand PrEP) at 6 months
Periodo de tiempo: 6 months
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Pharmacy-level; continuous outcome: Avg.
duration (in days) from on-demand PrEP dispensing to use, among on-demand clients
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6 months
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STI diagnosis
Periodo de tiempo: 18 months post implementation
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Individual-level; binary outcome: % of PrEP/PEP clients with a syndromic STI diagnosis (at any pharmacy PrEP/PEP visit)
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18 months post implementation
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Other drugs dispensed
Periodo de tiempo: 18 months post implementation
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Pharmacy-level; binary outcome: % of PrEP/PEP clients dispensed other drugs (e.g., hypertension, contraception) at their visit
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18 months post implementation
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HIV incidence
Periodo de tiempo: 18 months
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Pharmacy-level; binary outcome: % of PrEP/PEP clients who tested positive
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18 months
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HIV risk
Periodo de tiempo: 18 months post implementation
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Inidiviudal-level; binary outcome: % of PrEP/PEP clients reporting specific behaviors (i.e., multiple sex partners)
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18 months post implementation
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Kendall V Harkey, Fred Hutch Cancer Center
- Silla de estudio: Rachel C Malen, Fred Hutch Cancer Center
- Investigador principal: Katrina F Ortblad, Fred Hutch Cancer Center
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
31 de marzo de 2028
Finalización del estudio (Estimado)
30 de septiembre de 2028
Fechas de registro del estudio
Enviado por primera vez
24 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
24 de abril de 2026
Publicado por primera vez (Actual)
1 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
7 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- RG1125680
- R01MH140465 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Participant-level pharmacy record and research data will be shared through deposition of the data in an open-access public repository (Dryad).
In addition to sharing the study data publicly, data dictionaries and other tools supporting use of the data will be shared.
Marco de tiempo para compartir IPD
De-identified pharmacy record and research data from this study will be deposited in the Dryad data repository within 12 months of publication.
Criterios de acceso compartido de IPD
The study data will be accessible through the Dryad data repository. For all publications, a dataset will be created that is assigned a digital object identifier (DOI), which will be referenced in the publication so the research community can easily find and access the data, if interested. The Dryad repository can also be searched by topic, institution, and investigator name, which should make it easy for other interested parties to find and access the study data.
Any study data that cannot be shared via Dryad, will be made available through a formal request to the PIs. We will share data and supporting documentation upon request to outside investigators, after scientific review, IRB approval, and obtaining relevant Data Use Agreements.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .